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pdfMedicare Part B Average Sales Price
(ASP) Module
Submitter User Guide
Version 2.1
Date: August 29, 2025
CMS Proprietary
ASP Module Submitter User Guide
Table of Contents
1. Purpose................................................................................................................................. 1
2. Logging in Using MFA ........................................................................................................... 1
3. ASP Homepage Menu Tabs .................................................................................................. 7
3.1
3.2
3.3
3.4
3.5
3.6
3.7
Manage NDC1/ALT ID ................................................................................................. 7
3.1.1
Assign by NDC1 .............................................................................................. 8
3.1.2
Assign by Alternate ID....................................................................................10
3.1.3
Request New NDC1/ALT ID/Manufacturer/Generic Name .............................13
Product Data ............................................................................................................. 19
3.2.1
Add/Update Product Data ..............................................................................20
3.2.2
Upload Product Data ......................................................................................32
3.2.3
View Drugs ....................................................................................................36
Financial Data ........................................................................................................... 38
3.3.1
Add/Update Financial Data ............................................................................39
3.3.2
Add/Update Financial Data - Certified Drugs ..................................................45
3.3.3
Upload Financial Data ....................................................................................47
Restating Financial Data............................................................................................ 51
3.4.1
Add/Update Restate Financial Data ...............................................................52
3.4.2
Upload Restate Financial Data .......................................................................54
Compliance Summary ............................................................................................... 59
3.5.1
Missing...........................................................................................................60
3.5.2
Pending..........................................................................................................62
3.5.3
Certified .........................................................................................................64
3.5.4
New ...............................................................................................................67
3.5.5
Off Cycle ........................................................................................................68
3.5.6
Expired...........................................................................................................69
Generate One-Time Password .................................................................................. 70
Assumptions .............................................................................................................. 73
3.7.1
Reasonable Assumptions...............................................................................73
3.7.2
Other Assumptions.........................................................................................77
4. Technical Support Contact Information................................................................................ 80
Appendix A: Field Definitions .................................................................................................... 81
Appendix B: Revision History .................................................................................................... 85
Appendix C: Glossary ............................................................................................................... 86
Appendix D: Figures and Tables ............................................................................................... 88
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1.
Purpose
The purpose of this user guide is to provide guidance and instructions to representatives of drug
manufacturing companies as they submit federally required Medicare Part B drug Average
Sales Price (ASP) data to the Centers for Medicare & Medicaid Services (CMS).
CMS uses the Fee-for-Service Data Collection System (FFSDCS) to house various Fee-forService modules.
The ASP Data Collection System, referred to within this user guide as the ASP Module, is one
of the modules under the FFSDCS system, and offers the following:
•
•
•
•
•
Provides users with an online-based software application for automating the collection,
editing, and processing of drug product pricing data drug manufacturers submit on a
quarterly basis.
Establishes a relationship between the manufacturers’ reported data and the billing codes
Medicare providers use to calculate a weighted average sales price for each billing code.
Establishes prices for billing codes to determine payment limits of Part B drugs on certain
Medicare claims.
Eliminates data entry errors, data formatting errors, and incomplete submitted data, and
greatly reduces the process cycle and resource time needed to provide the pricing to
contractors through automation of the manually intensive processes.
Accepts, stores, validates, and calculates drug pricing on Medicare Part B drug data
received for the Center for Medicare Management (CMM) stakeholders.
Section 303 (b) and (c) of the Medicare Modernization Act (MMA) of 2003 revised the payment
methodology for the majority of Part B covered drugs and biologicals that are not priced on a
cost or prospective payment basis (hereafter referred to as drugs).
CMS applies the ASP methodology to the data drug manufacturers have submitted to the ASP
Module. Per the MMA, ASP methodology determines the payment limit for these drugs. Local
contractors calculate pricing for compounded drugs.
2.
Logging in Using MFA
First time users must register and create an account in the CMS Enterprise Portal before
logging in to the ASP Module. Refer to the Resource Library on the Education and Outreach
page to view the ASP Module Registration User Guide for registration steps.
Once registration is complete, follow these steps to log in to the ASP Module as a Submitter
using Multi-Factor Authentication (MFA):
1.
Navigate to the CMS Enterprise Portal main page.
The ASP Module Login Page opens. Refer to Figure 1.
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Figure 1: Logging in Using MFA - ASP Module Login
2.
3.
4.
Enter your login information in the required User ID and Password fields.
Click the Terms & Conditions hyperlink and review the text in the pop-up window; close
the window to move on to the next step.
Review the terms and conditions and select the I agree to the Terms & Conditions
checkbox.
Note: By selecting this checkbox, you certify that you read and consent to monitoring
while accessing and using the ASP Module. The terms and conditions link provides
additional hyperlinks to the HHS Rules of Behavior and the CMS Privacy Act Statement.
5.
Click Login.
Note: If you forget your user ID or password, click the Forgot your User ID or your
Password? hyperlink under the Login button and follow the provided instructions. If you
still cannot access your account and need to unlock it, click the Need to unlock your
account? hyperlink under Login button.
The Multi-Factor Authentication page opens. Refer to Figure 2.
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Figure 2: Logging in Using MFA - Select MFA Device Type Drop-Down Menu
To ensure the security of high value data submitted to the ASP Module, you must authenticate
your identity using an MFA process. The first time you attempt to log in, you must choose an
authentication method. Users have various authentication options, including Interactive Voice
Response (IVR), Email, Text Message (Short Message Service (SMS)), Google Authenticator
and Okta Verify.
6.
Click the Select MFA Device drop-down menu; select your preferred MFA device type
from the list. Whenever you log back into the ASP Module through this process, your
preferred method of MFA reloads automatically.
Note: Figure 3 demonstrates MFA registration using IVR as the selected option.
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Figure 3: Logging in Using MFA - Multi-Factor Authentication - (IVR) Example
7.
8.
9.
Enter your phone number in the Phone Number field; enter your extension in the
Extension field, if necessary.
Click the Send MFA Code button to receive a six-digit code via your chosen contact
method.
Record and enter the six-digit code you received into the Enter MFA Code field. Refer
to Figure 4.
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Figure 4: Logging in Using MFA - Multi-Factor Authentication - Verify MFA Code
10. Check the Send MFA code automatically and Do not challenge me on this device
for the next 30 minutes checkboxes depending on your preference.
Note: If you need help, click the Learn how to add MFA Devices beyond email and
Unable to Access MFA Devices or MFA Code? hyperlinks.
11. Click the Verify button to confirm your identity and enter the ASP Module homepage.
The My Portal landing page opens. Refer to Figure 5.
Figure 5: Logging in Using MFA - My Portal Landing Page
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Note: Other CMS applications you have access to may display on the My Portal landing
page.
12. Click the Fee For Service Data Collection System (FFSDCS) box.
A Fee for Service Data Collection System (FFSDCS) drop-down menu displays. Refer to
Figure 6.
Figure 6: Logging in Using MFA - My Portal Landing Page - FFSDCS Drop-down Menu
13. Click the Average Sales Price (ASP) hyperlink.
A full-page statement displays, titled ASP Data for Drugs and Biologics Covered
Under Medicare Part B. The statement details recent statutory requirements stated in
the Social Security Act (the Act), and the Consolidated Appropriations Act (CAA), 2021.
These requirements hold that manufacturers must report their ASP data to CMS with
precision on a quarterly basis without errors or miscalculations. Refer to Figure 7.
Figure 7: Logging in Using MFA - ASP Data for Drugs and Biologics Under Medicare Part B
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14. Read the statement; select the I have read the above statement checkbox and click
Submit.
The Medicare Part B Average Sales Price homepage opens. Refer to Figure 8.
Figure 8: Medicare Part B Average Sales Price Homepage
3.
ASP Homepage Menu Tabs
The following sections describe the functionality of each menu tab on the ASP homepage,
including Manage NDC1/ALT ID, Product Data, Financial Data, Compliance Summary,
Generate One-Time Password, Assumptions and FAQ.
Note: This user guide is written in order of the system menu tabs and the respective
tasks completed on that page and not necessarily in chronological order of steps to
follow for quarterly data submission.
3.1 Manage NDC1/ALT ID
The following sections describe how to assign NDC1s and Alternate IDs, as well as how to
request a new NDC1, Alternate ID, and manufacturer or generic name.
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Note: To add a new product, users must first request to add an NDC1/ALT ID and
Manufacturer/Generic Name, if needed. (Refer to Section 3.1.3 - Request New
NDC1/ALT ID/Manufacturer/Generic Name). Once the new product has been approved
into the system, users can establish the relationship between the manufacturer and the
product by assigning the NDC1/ALT ID to the manufacturer. (Refer to Section 3.1.1 Assign by NDC1 and Section 3.1.2 - Assign by Alternate ID.)
3.1.1
Assign by NDC1
Follow these steps to assign NDC1s:
1.
From the Medicare Part B Average Sales Price homepage, click the Manage NDC1/ALT
ID tab.
The Manage NDC1/ALT ID page opens and displays the Assign NDC1/ALT ID tab by
default. Refer to Figure 9.
Figure 9: Manage NDC1/ALT ID Page - Assign NDC1
2.
3.
From the Assign NDC1/ALT ID tab, select the NDC1 radio button to specify the product
data you need to submit to the Module.
Under NDC1 (required), click the -Select- drop-down menu to expand the list of
submitted drugs and additional products in the Module to date; select the appropriate
NDC1. Refer to Figure 10.
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Figure 10: Manage NDC1/ALT ID Page - Assign NDC1 Drop-down Menu
3.
Under Manufacturer Name (required), type and select the appropriate manufacturer.
Refer to Figure 11.
Figure 11: Manage NDC1/ALT ID Page - Enter NDC1 Manufacturer Name
4.
Click Assign to submit your information.
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A message displays confirming you have successfully added your selections. Refer to
Figure 12.
Figure 12: Manage NDC1/ALT ID - NDC1 Assigned Successfully
3.1.2
Assign by Alternate ID
Follow these steps to assign Alternate IDs:
1.
From the Medicare Part B Average Sales Price homepage, click the Manage NDC1/ALT
ID tab.
The Manage NDC1/ALT ID page opens and displays the Assign NDC1/ALT ID tab by
default.
2.
From the Assign NDC1/ALT ID tab, select the Alternate ID radio button.
Additional fields specific to assigning an Alternate ID display. Refer to Figure 13.
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Figure 13: Manage NDC1/ALT ID Page - Assign ALT ID
3.
Under Alternate ID (required), click the -Select- drop-down menu to expand the list of
submitted drugs and additional products in the Module to date; select the appropriate
alternate ID. Refer to Figure 14.
Figure 14: Manage NDC1/ALT ID Page - Assign ALT ID Drop-down Menu
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4.
In the Manufacturer Name (required) auto-fill field, begin to type the manufacturer
name; select the appropriate manufacturer from the list that generates. Refer to Figure
15.
Figure 15: Manage NDC1/ALT ID Page - Enter ALT ID Manufacturer Name
5.
Click Assign to submit your information.
A message displays confirming you have successfully added your selections. Refer to
Figure 16.
Figure 16: Manage NDC1/ALT ID - ALT ID Assigned Successfully
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3.1.3
Request New NDC1/ALT ID/Manufacturer/Generic Name
The following sections describe how to request a new NDC1, ALT ID, manufacturer, and
generic name.
3.1.3.1 Request New NDC1
Follow these steps to request a new NDC1:
1.
2.
Navigate to the Manage NDC1/ALT ID page, which automatically opens on the Assign
NDC1/ALT ID tab.
Click the Request New NDC1/ALT ID/Manufacturer/Generic Name tab.
The Request New NDC1/ALT ID/Manufacturer/Generic Name page opens, showing
the status (Pending, Approved, or Rejected) for each submitted request. The Module
organizes data by Request Type, Requested Value as well as Request Date and
Status (Pending, Approved, or Rejected). Refer to Figure 17.
Figure 17: Request New NDC1/ALT ID/Manufacturer/Generic Name Page
3.
Click the Add New Request button.
An Add New NDC1/ALT ID/Manufacturer/Generic Name window opens. Refer to
Figure 18.
Figure 18: Request New NDC1/ALT ID/Manufacturer/Generic Name Page - Add New NDC1
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4.
5.
Select the New NDC1 radio button to specify the product data you need to submit to the
Module. Note that the Module automatically defaults to select the New NDC1.
Under New NDC1 (required), enter the appropriate NDC for the data product you are
requesting to add to the Module. Refer to Figure 19.
Figure 19: Request New NDC1 - Field Filled
6.
Click Send Request to submit your information.
A message displays confirming you have successfully added your selections. Refer to
Figure 20.
Figure 20: Request New NDC1 - NDC1 Successfully Added
3.1.3.2 Request New ALT ID
Follow these steps to request a new Alternate ID:
1.
Click the Add New Request button. Refer to Figure 20.
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An Add New NDC1/ALT ID/Manufacturer/Generic Name window opens. Note that the
Module automatically defaults to the New NDC1 tab.
2.
Select the New Alternate ID radio button to specify the product data you need to submit
to the Module. Refer to Figure 21.
Figure 21: Request New NDC1/ALT ID/Manufacturer/Generic Name Page - Add New ALT ID
3.
Under New Alternate ID (required), enter the appropriate alternate ID for the product
you want to add to the Module.
Note: An Alternate ID is a manufacturer-selected product identifier that can be any
combination of letters or numbers unique to the product (i.e., Stock Keeping Number
(SKN) or product number). The New Alternate ID field allows up to a maximum of 23
characters and special characters (colon, dash, or period).
4.
Under Alternate ID Website URL (required), enter the hyperlink for the drug
manufacturer’s website. Refer to Figure 22.
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Figure 22: Request New Alternate ID - ALT ID Field Filled
5.
Click the Send Request button to submit your information.
A message displays confirming you have successfully added your selections. Refer to
Figure 23.
Figure 23: Request New Alternate ID - ALT ID Successfully Added
3.1.3.3 Request New Manufacturer Name or New Generic Name
Follow these steps to request a New Manufacturer or New Generic Name:
1.
Click the Add New Request button. Refer to Figure 23.
An Add New NDC1/ALT ID/Manufacturer/Generic Name window opens. Note that the
Module automatically defaults to the New NDC1 tab.
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2.
Select either the New Manufacturer Name or the New Generic Name radio button to
specify the product data you need to submit to the Module.
Additional fields display as the next page opens for either selection. Refer to Figure 24
and Figure 25.
Figure 24: Request New Manufacturer Name
Figure 25: Request New Generic Name
3.
Under New Manufacturer Name (required) or New Generic Name (required), enter
the appropriate information for the data product you want to add to the Module. Refer to
Figure 26 and Figure 27.
Note: For New Manufacturer Name requests, users will need to submit business
identification information including the manufacturer’s Employer Identification Number
(EIN) and Data Universal Numbering System (DUNS) number.
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Figure 26: Request New Manufacturer Name - Field Populated
Figure 27: Request New Generic Name - Field Populated
4.
Click Send Request to submit your information for either selection.
A message displays confirming you have successfully added your selections. Refer to
Figure 28 and Figure 29.
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Figure 28: Request New Manufacturer Name - Successfully Added
Figure 29: Request New Generic Name - Successfully Added
Note: ASP support staff complete requests to add new items. Contact
[email protected] for further questions or concerns about the process.
3.2 Product Data
Drug manufacturers must submit quarterly drug pricing data using a file transfer process, or
through online data entry in the ASP module. Drug data consists of product and financial data.
Click the Product Data tab on the Medicare Part B Average Sales Price homepage to view the
drop-down menu for the Add/Update Product Data, Upload Product Data, and View Drugs
tabs. Refer to Figure 30.
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Figure 30: Product Data - Main Drop-down Menu
The following sections describe how to add/update, upload product data, and view drugs.
3.2.1
Add/Update Product Data
Follow these steps to add and/or update product data:
1.
From the Medicare Part B Average Sales Price homepage, click the Product Data tab;
then select the Add/Update Product Data tab.
The Add/Update Product Data page opens with default selections. Refer to Figure 31.
Figure 31: Add/Update Product Data
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Note: It is imperative that the spelling matches each time you enter product data for the
same drug manufacturer. The spelling must also match when entering data under the
Upload Product Data tab.
3.2.1.1 Add Product Data by NDC
Follow these steps to add product data by NDC:
1.
2.
3.
4.
5.
From the Add Product Data page, select the Add by NDC radio button if it is not
already selected when the page opens.
In the Manufacturer Name (required) field, begin to type and then select the
appropriate manufacturer.
Under NDC1 (required), click the -Select- drop-down menu to expand the list of
submitted drugs and additional products in the Module to date; select your required
NDC1* code.
Enter your 4-digit number in the NDC2* (required) field.
Enter your 2-digit number in the NDC3* (required) field.
As you complete the NDC3* (required) field, the Add Product Data page expands to
display multiple drop-down menus and empty fields.
6.
Enter or select the required information as follows:
a. Select the Drug has brand name checkbox if the product you are submitting has a
brand name. (If so, an empty field displays to submit the brand name; type
information here as needed.)
b. Click the Generic Name (required) drop-down menu; select the generic name you
need to enter for your product.
Note: Return to the Manage NDC1/ALT ID page if you cannot find the appropriate
generic name in the system. Refer to Section 3.1 - Manage NDC1/ALT ID for guidance.
c. Enter the volume per item in the Volume Per Item (required) field.
d. Click the Unit for Volume Per Item (required) drop-down; select the appropriate
option for your product.
e. Enter the appropriate number in the Number of Items per NDC (required) field.
f. Click the Package Type (required) drop-down; select the appropriate package
type.
g. Enter the strength in the Strength (required) field.
h. Click the Unit for Strength (required) drop-down; select the appropriate unit.
i. Enter the FDA application number in the FDA Application Number (required)
field.
j. Enter the FDA application supplement number in the FDA Application
Supplement Number field, if applicable.
Note: Click the Add Additional FDA Application Numbers button if applicable for the
drug, and repeat steps i and j.
k.
l.
Enter the FDA approval date in the FDA Approval Date (required) field.
Click the FDA Approval Type (required) drop-down; select the appropriate
approval type.
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m. Enter the first marketing date in the First Marketing Date (required) field.
n. Enter the date of first sale in the Date of First Sale (required) field.
o. Enter the WAC in the Wholesale Acquisition Cost (required) field.
Note: The Wholesale Acquisition Cost (required) field is required and displays when
the First Marketing Date occurs after the current reporting period.
Note: The date of first sale cannot occur before the FDA approval date and must occur
prior to the current reporting period start date.
7.
Confirm your selections. Refer to Figure 32.
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Figure 32: Add/Update Product Data Fields Populated
8.
Click Add Product Data to submit your information.
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A message displays confirming you have successfully added your selections. Refer to
Figure 33.
Figure 33: Add/Update Product Data Successfully Added
Note: It is imperative that the spelling matches each time you enter product data for the
same drug manufacturer. The spelling must also match when entering data under the
Upload Product Data tab.
3.2.1.2 Add Product Data by Alternate ID
Follow these steps to add product data by alternate ID:
1.
From the Add/Update Product Data page, select the Add by Alternate ID radio button.
The Add Product Data page expands to display additional empty fields. Refer to Figure
34.
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Figure 34: Add Product Data by Alternate ID
2.
3.
Under Manufacturer Name (required), begin to type and then select the appropriate
manufacturer.
Under Alternate ID (required), click the -Select- drop-down to expand the list. Select
the required alternate ID code. Refer to Figure 35.
Figure 35: Add Product Data by Alternate ID - Fields Populated
As you complete the Alternate ID (required) field, the Add Product Data page expands
to show multiple drop-down menus and empty fields.
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4.
Enter or select the required information as follows:
a. Enter the uniform resource locator (URL) to the manufacturer website in the
Manufacturer’s Website URL (required) field for verification purposes.
b. Select the Drug has a brand name checkbox if the product you are submitting has a
brand name. (If so, an empty field displays in which to enter the brand name; type
information here as needed.)
c. Click the Generic Name (required) drop-down; select the generic name you need to
enter for your product.
Note: Return to the Manage NDC1/ALT ID page if you cannot find the appropriate
generic name in the system. Refer to Section 3.1 - Manage NDC1/ALT ID for guidance.
d. Enter the volume per item in the Volume Per Item (required) field.
e. Click the Unit for Volume Per Item (required) drop-down; select the appropriate
option for your product.
Note: For skin substitute products such as powders, sheets or discs, enter “One” for
Volume and “Each” for Unit for Volume.
f.
Enter the appropriate number in the Number of Items per Alternate ID (required)
field.
g. Click the Package Type (required) drop-down; select the appropriate package type.
Package Type is not applicable to skin substitute sheets.
h. Enter the strength in the Strength (required) field.
Note: For skin substitute products, strength is determined by calculating the area of the
product.
i.
j.
k.
l.
m.
n.
Click the Unit for Strength (required) drop-down; select the appropriate unit.
Enter the FDA registration number in the FDA Registration Number (required) field.
Enter the FDA approval date in the FDA Approval Date (required) field.
Enter the FDA approval type in the FDA Approval Type (required) field.
Enter the first marketing date in the First Marketing Date (required) field.
Enter the date of first sale in the Date of First Sale for this ALT ID (required) field.
Note: The date of first sale cannot occur before the FDA approval date and must occur
prior to the current reporting period start date.
5.
Confirm your selections; click Add Product Data to submit your information. Refer to
Figure 36.
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Figure 36: Add Product Data by Alternate ID - Additional Fields
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A message displays confirming you have successfully added your product data. Refer to
Figure 37.
Figure 37: Product Data by Alternate ID Added Successfully
Note: It is imperative that the spelling matches each time you enter product data for the
same drug manufacturer. The spelling must also match when entering data under the
Upload Product Data tab.
3.2.1.3 Update Product Data by NDC
Follow these steps to update product data by NDC:
1.
From the Add/Update Product Data page, select the Update Product Data tab; then,
select the Update by NDC radio button if it is not already selected when the page
opens. Refer to Figure 38.
Figure 38: Update Product Data - Drug Identifier & Manufacturer Name
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2.
In the Drug Identifier & Manufacturer Name (required) drop-down menu, click Select- to expand the list of submitted drugs and additional products in the Module to
date; select the appropriate drug identifier.
The page automatically loads the product data for that specific drug. Refer to Figure 39.
Figure 39: Update Product Data by NDC
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3.
4.
Review all your information in the appropriate boxes previously submitted in Section 3.2
- Product Data.
Confirm your selections; click Update Product Data to submit any changes in your drug
product data.
A message displays confirming you have successfully updated your product data. Refer
to Figure 40.
Figure 40: Update Product Data by NDC - Data Updated Successfully
3.2.1.4 Update Product Data by Alternate ID
Follow these steps to update product data by Alternate ID:
1.
From the Add/Update Product Data page, select the Update Product Data tab; then,
select the Update by Alternate ID radio button. Refer to Figure 41.
Figure 41: Update Product Data by Alternate ID
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2.
Under the Alternate ID & Manufacturer Name (required) drop-down; click the -Selectdrop-down to expand the list; select the appropriate information.
The page automatically loads the product data for that specific drug. Refer to Figure 42.
Note: Additional fields display on the next page. Ensure that you complete all required
fields, and that all added financial information is accurate.
Figure 42: Update Product Data by Alternate ID - Drug Identifier Drop-down Menu
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3.
4.
Review all your information in the appropriate boxes previously submitted in Section 3.2
- Product Data.
Confirm your selections; click Update Product Data to submit any changes in your drug
product data.
A message displays confirming you have successfully updated your product data. Refer
to Figure 43.
Figure 43: Update Product Data by Alternate ID - Updated Successfully
3.2.2
Upload Product Data
Follow these steps to upload product data:
1.
From the Medicare Part B Average Sales Price homepage, click the Product Data tab;
then select the Upload Product Data tab.
The Upload Product Data page opens, listing the financial quarter and year for the
upcoming reporting period. Refer to Figure 44.
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Figure 44: Upload Product Data - New or Corrected
Note: Click the Product Data Template (Excel) box to download a copy of the product
data template.
2.
Upon preparing your .xlsx file (required) and verifying your information for accuracy,
click Select File; then select the Excel file in the dialog box. You may also drag the file
into the Select File box. Refer to Figure 45.
Figure 45: Upload Product Data - Uploading Files from Desktop
A download bar displays as your file uploads. A message displays confirming you have
successfully uploaded your .xlsx file. Refer to Figure 46.
Note: If the Module cannot process your file, an error message displays, and a New
Report generates under Uploaded Files.
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Figure 46: Upload Product Data - New File Successfully Uploaded
3.
Refresh your browser to allow the system to update and display your new file.
The Uploaded Files section displays files you uploaded recently as well as previous
files still in the Module. Refer to Figure 47.
Figure 47: Upload Product Data - Uploaded Files
Each uploaded file displays the File Name, Upload Date, Reporting Period, Total
Records, Total Accepted, Total Rejected, and Action categories submitted to the
Module.
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4.
Click View Report under Action in the Uploaded Files section to view the full report for
a submitted file.
The report opens on the next page. Refer to Figure 48.
Figure 48: Upload Product Data - Full Report of Transmitted Drugs via File Upload
5.
Click the Read More tab under the Report of Transmitted Drugs via File Upload to
view all File Processing Information related to this report.
The report lists all uploaded drugs with saved product data in the ASP system. The
Module organizes the full list by row number and includes each drug identifier, status,
and all previously submitted information from the Add Product Data sections.
Note: The Module highlights errors in red. Hover over the red text to display information
about the specific error.
6.
Click the Rejection Details tab.
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A listing of drugs with rejected product data displays. Refer to Figure 49.
Figure 49: Upload Product Data - Reported Rejection Details
The Module lists all errors found in submitted data by Row Number, Column with
Error, and Error Message under Drugs with Rejected Product Data.
7.
3.2.3
Return to the Add/Update Product Data section of the Module to request any changes
to your product data.
View Drugs
Drug manufacturers can use the ASP module to view drug data submitted during the current
reporting period. However, manufacturers cannot update or edit drug data using this feature.
From the Medicare Part B Average Sales Price homepage, click the Product Data tab; then
select the View Drugs tab to view the View Drugs page.
The following sections describe how to view active and expired drugs.
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3.2.3.1 View Active Drugs
From the View Drugs page, the Active Drugs tab displays by default. Refer to Figure 50.
Figure 50: Product Data - View Active Drugs
Follow these steps to view submitted drug data for Active Drugs from the View Drugs page:
1.
Scroll through the list of active drugs to view submitted data and status.
The Module organizes all active drugs by Drug Identifier, Manufacturer Name,
Generic Name, Brand Name, Volume per Item, Unit for Volume per Item, Number of
Items per NDC, Package Type, and Strength categories, and previously submitted
information from the Add Product Data sections.
2.
Click the arrows on the bottom left to scroll through all submitted drugs by page. View,
filter, and sort active drugs by clicking on the category name.
Note: Click the Export to Excel button to download all products under the Compliance
Summary.
3.2.3.2 View Expired Drugs
Follow these steps to view submitted drug data for Expired Drugs:
1.
From the View Drugs page, select the Expired Drugs tab.
The Expired Drugs page opens. Refer to Figure 51.
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Figure 51: Product Data - View Expired Drugs
2.
Scroll through the list of expired drugs to view submitted data and status.
The Module organizes expired drugs by Drug Identifier, Manufacturer Name, Generic
Name, Brand Name, Volume per Item, Unit for Volume per Item, Number of Items
per NDC, Package Type, and Strength categories, and previously submitted
information from the Add Product Data sections.
3.
4.
Click the arrows on the bottom left to scroll through all submitted drugs by page. View,
filter, and sort active drugs by clicking on the category name.
Click the Export to Excel button to download all expired drug products.
3.3 Financial Data
Click the Financial Data tab on the Medicare Part B Average Sales Price homepage to view the
drop-down menu tabs, Add/Update Financial Data for Current Quarter, Upload Financial
Data for Current Quarter, Restate Financial Data or Add for Prior Quarters, and Upload
Financial Data for Prior Quarters. Refer to Figure 52.
Figure 52: Financial Data - Main Drop-down
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The following sections describe how to add/update and upload financial data.
3.3.1
Add/Update Financial Data
To add or update financial data, click the Add/Update Financial Data for Current Quarter tab.
Note: If you are a manufacturer of certain drugs that contain variable amounts of
product, such as radiopharmaceuticals and blood clotting factors, your data should be
reported to CMS at the HCPCS level rather than the NDC level. CMS maintains and
publishes a list of these drugs on a quarterly basis on the ASP Reporting page under the
Reporting Resources section. If you are a manufacturer of a drug that contains variable
amounts of product, please check the “ASP Report in Units Other than NDC”
document prior to submitting your financial data for the quarter. Should you have any
questions, please contact [email protected].
The Add/Update Financial Data page opens with default selections. Refer to Figure 53.
Figure 53: Add/Update Financial Data
Note: The Module collects data submissions for the upcoming financial quarter. As an
example, figures in this section feature data submitted for Q1 2023.
The next section describes steps to indicate if your 505(b)(2) products have any therapeutic
equivalent changes. If this is not applicable to you, you may skip ahead to the next section,
Section 3.3.1.2 - Add/Update Financial Data for Uncertified Drugs.
3.3.1.1 Add Therapeutic Equivalent Changes for 505(b)(2) Drugs
If you are associated with any 505(b)(2) products, the system displays a prompt to review the
list of products and indicate if any of those products have therapeutic equivalent changes. Refer
to Figure 54.
Note: If you are associated with any 505(b)(2) products, you must complete these steps
before proceeding with adding or editing data. If you are not associated with 505(b)(2)
products or are a new user, skip ahead to Section 3.3.1.2 - Add/Update Financial Data
for Uncertified Drugs.
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Figure 54: Add/Update Financial Data 505(b)(2)
Follow these steps to review your list of products and indicate any therapeutic equivalent
changes:
Click the list hyperlink in the prompt. Refer to Figure 54.The list of products displays.
5.
Select Yes or No in the drop-down menu for each product to indicate whether your
product has a therapeutic equivalent. Refer to Figure 56 and Figure 56.
Figure 55: Add/Update Financial Data 505(b)(2) Products List
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Figure 56: Add/Update Financial Data 505(b)(2) Products List
6.
Once you have reviewed the list and made your selections, click Save and Confirm.
A confirmation message displays asking if you have reviewed all of your products.
7.
If you have finished reviewing your products, click Confirm. Refer to Figure 57.
Figure 57: 505(b)(2) Confirmation
A message displays confirming you have successfully updated your therapeutic
changes. Refer Figure 58.
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Figure 58: Add/Update Financial Data 505(b)(2) Successfully Updated
3.3.1.2 Add/Update Financial Data for Uncertified Drugs
Follow these steps to add/update financial data for uncertified drugs:
1.
From the Add/Update Financial Data page, select the Uncertified Drugs tab if it is not
already selected.
Note: The Module denotes the Manufacturer’s ASP, Number of ASP Units, and
Wholesale Acquisition Cost fields with an (*) to indicate that each field is required.
2.
3.
Enter or edit any missing or inaccurate financial data for your submitted drug products.
As you add or update information onto the page, click the Save All button to save your
changes in the Module.
Note: As an alternative to entering data directly into the Module, under Drug Identifiers
with Missing or Incorrect Financial Data, you can click the Excel box on the right side
to convert all information on this page into an Excel file. You can upload the Excel file
after making your updates. Refer to Section 3.3.3 - Upload Financial Data.
4.
5.
Scroll through the list of submitted drugs and products on the page. Filter through all the
information by clicking on the category name.
Click the plus symbol on each row of the table to expand each product’s information and
view additional categories, including Brand Name, FDA Approval and all other
information previously submitted or acknowledged in the Product Data section. Refer to
Figure 59.
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Figure 59: Add/Update Financial Data - Drug Identifiers With Missing or Incorrect Data
6.
7.
Enter and review your information to ensure the highest level of accuracy in data
reporting.
Click the Save All button to submit your information to the Module.
A message displays confirming you have successfully updated your financial data. Refer
to Figure 60.
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Figure 60: Add/Update Financial Data Successfully Added
Note: When there is an error in the submitted data or a missing field, the page highlights
each box in yellow to flag an error.
Each row with errors displays a View Alerts button. Refer to Figure 61.
Figure 61: Add/Update Financial Data - Error Menu
8.
Click the View Alerts button for more information regarding the data reporting errors in
your submitted financial data.
A side panel opens and displays a listing with descriptions of various errors and
warnings. Refer to Figure 62.
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Figure 62: Add/Update Financial Data - View Errors/Warnings Page
9.
Click Save Changes once you address any errors and confirm your product data is
accurate.
A message displays confirming that you have successfully added your data. Refer to
Figure 63.
Figure 63: Add/Update Financial Data - Successfully Updated
3.3.2
Add/Update Financial Data - Certified Drugs
The Module collects data submissions for the upcoming financial quarter. Follow these steps to
view submitted data for certified drugs:
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1.
From the Add/Update Financial Data page, select the Certified Drugs tab.
The Certified Drugs page opens. Refer to Figure 64.
Figure 64: Add/Update Financial Data - Certified Drugs
Note: To update financial data for Certified drug identifiers, refer to the steps in Section
3.4.1- Add/Update Restate Financial Data.
2.
Under Drug Identifiers certified, click the Export to Excel button to convert all
information on this page into an Excel file.
Note: The Module denotes the Manufacturer’s ASP, Number of ASP Units, and
Wholesale Acquisition Cost fields with an (*) to indicate that each field is required.
3.
4.
5.
Scroll through the list of certified drugs and products on the page. Filter through all the
information by clicking on your preferred category name.
Click the arrows on the bottom left to scroll through all submitted drugs by page.
Click on the plus symbol on each row of the table to expand each product’s information
and view additional categories, including Brand Name, FDA Approval and all other
information previously submitted or acknowledged in the Product Data section. Refer to
Figure 65.
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Figure 65: Add/Update Financial Data - Certified Drugs More Information
3.3.3
Upload Financial Data
Follow these steps to upload financial data:
1.
2.
From the Medicare Part B Average Sales Price homepage, click the Financial Data tab;
then select the Upload Financial Data for Current Quarter tab.
The Upload New or Corrected Financial Data page opens, listing the financial quarter
and year for the upcoming reporting period. Refer to Figure 66.
Figure 66: Upload Product Data - New or Corrected
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Note: Under Data being submitted for: (current quarter), click Financial Data
Template (Excel) to download a financial data template.
3.
4.
If you are associated with any 505(b)(2) products, you may be prompted to indicate if
your products have any therapeutic equivalent changes before you can proceed. Refer
to Section 3.3.1.1 - Add Therapeutic Equivalent Changes for 505(b)(2) Drugs for more
information.
Upon preparing your .xlsx file (required) and verifying your information for accuracy,
click Select File to browse your desktop and upload the file to the Module. You may also
drag the file into the Select File box. Refer to Figure 67.
Figure 67: Upload Financial Data - Uploading Files From Desktop
A download bar displays as your file uploads. A message displays confirming you have
successfully uploaded your .xlsx file. Refer to Figure 68.
Note: If the Module cannot process your file, an error message displays, and a New
Report generates under Uploaded Files.
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Figure 68: Upload Financial Data Page - New File Successfully Uploaded
5.
The Uploaded Files section displays files you uploaded recently as well as previous
files still in the Module. Refer to Figure 69.
Figure 69: Upload Financial Data - Uploaded Files
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Each uploaded file displays the File Name, Status, Upload Date, Reporting Period,
Total Records, Total Accepted, Total Rejected, and Actions categories submitted to
the Module.
6.
Click View Report under Actions in the Uploaded Files section to view the full report
for a submitted file.
The report opens on the next page. Refer to Figure 70.
Figure 70: Upload Financial Data - Report of Transmitted Drugs via File Upload
The report lists all drugs with saved product data in the ASP system. The Module
organizes the full list by row number and includes each drug identifier, status, and all
previously submitted information from the Add Product Data sections.
Note: The Module highlights errors in red. Hover over the red text to display information
about the specific error.
7.
Click the Rejection Details tab.
A listing of drug identifiers with rejected financial data displays. Refer to Figure 71.
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Figure 71: Upload Financial Data - Reported Rejection Details
The Module lists all errors found in submitted data by Row Number, Column with
Error, Value and Error Message under Drugs with rejected financial data.
8.
Return to the Add/Update Financial Data for Current Quarter section of the Module to
request any changes to your product data.
3.4 Restating Financial Data
Manufacturers of drugs and biologicals payable under Medicare Part B have an obligation to
report accurate ASP data to CMS, including addressing data miscalculations and other errors in
previously submitted data. Upon identifying an error, manufacturers must submit corrected data
through the ASP Module. Additionally, CMS may identify an error and contact the manufacturer
to request corrected data for prior quarters.
CMS evaluates resubmitted data and decides whether to issue a restatement of the payment
limit. Criteria evaluated includes, but is not limited to, timing of the corrected data, changes to
the payment limit, and/or administrative burden.
The following sections describe how to add/update or upload restate financial data using the
online data entry process.
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3.4.1
Add/Update Restate Financial Data
Follow these steps to add/update restate financial data:
1.
Click the Financial Data tab; select Restate Financial Data or Add for Prior Quarters.
Refer to Figure 72.
Figure 72: Financial Data - Main Dropdown
The Restate Financial Data or Add for Prior Quarters page opens, listing the financial
quarter and year for the upcoming reporting period. Refer to Figure 73.
Figure 73: Financial Data - Add/Update Restate Financial Data
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Note: Click the Restatement Period (required) drop-down in the top left to scroll
through previous quarters. Click the blue arrows to navigate to a previous quarter
starting with the most recent or next quarter.
2.
Click the -Select- box under Drug Identifier (required) to expand the list of submitted
drugs in the Module. Refer to Figure 74.
Figure 74: Add/Update Restate Financial Data - Drug Identifier Drop-down
Select the Drug Identifier you need to close the drop-down. Once you click a product, the
Review Restatement List expands to show the selected restatement. Refer to Figure 75.
Figure 75: Add/Update Restate Page - Review Restatement List
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3.
4.
5.
Review and make any corrections necessary for the drug to the Manufacturer’s ASP,
Number of ASP Units, Wholesale Acquisition Cost (all required) and Average
Wholesale Price fields.
Click the plus symbol on each row of the table to expand each product’s information and
view additional categories previously submitted or acknowledged in the Product Data
section.
Click the Save button to submit your data.
A message displays confirming you have successfully updated your Restate Financial
Data. Refer to Figure 76.
Figure 76: Add/Update Restate Page - Restate Data Successfully Saved
6.
3.4.2
Contact your Certifier to recertify the corrected data you submitted to the Module.
Upload Restate Financial Data
Follow these steps to upload restate financial data:
1.
From the Medicare Part B Average Sales Price homepage, click the Financial Data tab;
then select Upload Financial Data for Prior Quarters. Refer to Figure 77.
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Figure 77: Financial Data - Main Drop-down
The Upload Financial Data for Prior Quarters page opens, listing the financial quarter
and year for the upcoming reporting period. Refer to Figure 78.
Figure 78: Upload Financial Data for Prior Quarters Restate Financial Data
Note: Under Upload New or Corrected Financial Data, there is a Restatement
Financial Data Template (Excel) available for download. Click the button to download a
desktop copy.
2.
Upon preparing your .xlsx file (required) and verifying your information for accuracy,
click Select File to browse your desktop and upload the file to the Module. You may also
drag the file into the Select File box. Refer to Figure 79.
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Figure 79: Upload Financial Data for Prior Quarters - Uploading Files From Desktop
A download bar displays as your file uploads. A message displays confirming you have
successfully uploaded your .xlsx file. Refer to Figure 80.
Note: If the Module cannot process your file, an error message displays, and a New
Report generates under Uploaded Files.
Figure 80: Upload Financial Data for Prior Quarters - New File Successfully Uploaded
The Uploaded Files section displays files you uploaded recently as well as previous
files still in the Module. Refer to Figure 81.
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Figure 81: Upload Financial Data for Prior Quarters - Uploaded Files
Each uploaded file displays the File Name, Status, Upload Date, Reporting Period,
Total Records, Total Accepted, Total Rejected, and Actions categories submitted to
the Module.
3.
Click View Report under Actions in the Uploaded Files section to view the full report
for a submitted file.
The report opens on the next page. Refer to Figure 82.
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Figure 82: Upload Financial Data for Prior Quarters - Report of Transmitted Drugs
The report lists all drug identifiers with saved restate financial data in the ASP system.
The Module organizes the full list by row number and includes each drug identifier,
status, and other previously submitted information from the Add Product Data sections.
Note: The Module highlights errors in red. Hover over the red text to display information
about the specific error.
4.
Click the Rejection Details tab.
A listing of drug identifiers with rejected restate financial data displays. Refer to Figure
83.
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Figure 83: Upload Financial Data for Prior Quarters - Reported Rejection Details
The Module lists all errors found in submitted data by Row Number, Column with
Error, Value and Error Message under Drugs with rejected financial data.
5.
6.
Return to the Add/Update Financial Data section of the Module to request any changes
to your product data.
Contact your Certifier to recertify the corrected data you submitted to the Module.
3.5 Compliance Summary
The features in the Compliance Summary section allow drug manufacturers to determine if
their products meet the current submission reporting requirements.
The Compliance Summary consists of the following sections:
•
•
•
Missing: Displays drug products that are missing financial data for the selected reporting
period.
Pending: Displays drug products that are both pending certification and pending
restatement certification, combined under one tab.
Certified: Displays previously certified drug products for the selected reporting period.
Note: Financial data will be suppressed for prior quarters.
•
•
New: Displays drug products with a first marketing date in the same reporting period.
Off Cycle: Displays drug products added on or after the first day of the submission
window of the current quarter.
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•
Expired: Displays drug products that have an expired date of final lot sold. A drug
product that expired in an earlier quarter will continue to show in subsequent quarters.
Follow these steps to navigate the Compliance Summary section:
1.
From the Medicare Part B Average Sales Price homepage, click the Compliance
Summary tab.
The Compliance Summary page opens. The page displays the status for each
submitted drug product regarding the drug manufacturer’s compliance for the selected
reporting period. The page automatically defaults to the Missing tab. Refer to Figure 84.
Note: Figure 84 shows an alert message under Reporting Period stating that there are
drug products in need of attention.
Figure 84: Compliance Summary
Note: Click the Reporting Period (required) tab in the top left to scroll through previous
quarters. Click the blue arrows to navigate to a previous quarter starting with the most
recent or next quarter.
3.5.1
Missing
Follow these steps to add data in the Missing tab of the Compliance Summary:
1.
Under Drug Identifiers waiting for data entry, review and identify the missing fields or
incorrect financial information to address; confirm the accuracy of all the necessary
financial information listed on the page.
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The Module organizes the full list by Drug Identifier and Manufacturer Name, and
includes Reporting Period, Manufacturer’s ASP, Number of ASP Units, Wholesale
Acquisition Cost, and Average Wholesale Price fields.
Note: Click the Export to Excel button to download all products under the Missing tab.
2.
Click the Add Data tab next to the appropriate drug product.
An Add Financial Data window opens. Refer to Figure 85.
Figure 85: Compliance Summary - Add Data Screen
3.
4.
Type the requested information in the empty Manufacturer’s ASP (required), Number
of ASP Units (required), Wholesale Acquisition Cost (required), and Average
Wholesale Price (required) fields.
Click Save to submit your information to the Module.
A message displays confirming you have successfully added your data, and that your
product is now pending certification. Refer to Figure 86.
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Figure 86: Compliance Summary - Successfully Saved
3.5.2
Pending
Follow these steps to review your data in the Pending tab of the Compliance Summary:
1.
From the default Compliance Summary page, click the Pending tab.
The Pending tab displays. Refer to Figure 87.
Figure 87: Compliance Summary - All Pending Certification
The Module automatically selects the All Pending Certification radio button, and the
page displays the drug identifiers waiting for certification/restatement certification.
Note: Click the Export to Excel button to download all products under the Pending tab.
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2.
Under Drug Identifiers Waiting for Certification/Restatement Certification, review
your information in the appropriate boxes previously submitted in Section 3.2 - Product
Data and Section 3.3 - Financial Data.
The Module organizes the full list by Drug Identifier and Manufacturer Name, and
includes Reporting Period, Manufacturer’s ASP, Number of ASP Units, Wholesale
Acquisition Cost, Average Wholesale Price, and Status fields.
3.
Click the Pending Certification radio button to filter only for drugs pending certification.
Refer to Figure 88.
Figure 88: Compliance Summary - Pending Certification
Note: Click the Export to Excel box to download all products under the Pending tab.
4.
Review the information previously submitted in Section 3.2 - Product Data.
The Module organizes the full list by Drug Identifier and Manufacturer Name, and
includes Reporting Period, Manufacturer’s ASP, Number of ASP Units, Wholesale
Acquisition Cost, Average Wholesale Price, and Status fields.
5.
Click the Pending Restatement Certification radio button to filter only for drugs that
are pending restatement certification. Refer to Figure 89.
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Figure 89: Compliance Summary - Pending Restatement Certification
Note: Click the Export to Excel button to download all products under the Pending tab.
6.
Review all your information in the appropriate boxes previously submitted in Section 3.2
- Product Data and Section 3.3 - Financial Data.
The Module organizes the full list by Drug Identifier and Manufacturer Name, and
includes Reporting Period, Manufacturer’s ASP, Number of ASP Units, Wholesale
Acquisition Cost, and Average Wholesale Price, and Status fields.
3.5.3
Certified
Follow these steps to review your data in the Certified tab of the Compliance Summary:
1.
From the default Compliance Summary page, click the Certified tab.
The Certified page displays. The Module automatically selects the All Certified radio
button. Refer to Figure 90.
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Figure 90: Compliance Summary - All Certified
Note: Click the Export to Excel button to download all products under the Certified tab.
2.
Review all your information in the appropriate boxes previously submitted in Section 3.2
- Product Data and Section 3.3 - Financial Data.
The Module organizes the full list by Drug Identifier and Manufacturer Name, and
includes Reporting Period, Manufacturer’s ASP, Number of ASP Units, Wholesale
Acquisition Cost, and Average Wholesale Price, and Status fields.
3.
Click the Certified radio button to filter only for certified drugs. Refer to Figure 91.
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Figure 91: Compliance Summary - Certified
Note: Click the Export to Excel button to download all products under the Certified tab.
4.
Review your information for accuracy.
The Module organizes the full list by Drug Identifier and Manufacturer Name, and
includes Reporting Period, Manufacturer’s ASP, Number of ASP Units, Wholesale
Acquisition Cost, and Average Wholesale Price, and Status fields.
5.
Click the Restated and Certified radio button to filter only for restated and certified
drugs. Refer to Figure 92.
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Figure 92: Compliance Summary - Restated and Certified
Note: Click the Export to Excel box if you need to download all products under the
Certified tab.
6.
Review your information for accuracy.
The Module organizes the full list by Drug Identifier and Manufacturer Name, and
includes Reporting Period, Manufacturer’s ASP, Number of ASP Units, Wholesale
Acquisition Cost, and Average Wholesale Price, and Status fields.
3.5.4
New
Follow these steps to review your data in the New tab of the Compliance Summary:
1.
From the default Compliance Summary page, click the New tab.
The New page displays. Refer to Figure 93.
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Figure 93: Compliance Summary - New
Note: Click the Export to Excel button to download all products under the New tab.
2.
Review your information for accuracy.
The Module organizes the full list by Drug Identifier and Manufacturer Name, and
includes Reporting Period, Manufacturer’s ASP, Number of ASP Units, Wholesale
Acquisition Cost, and Average Wholesale Price, and Status fields.
3.5.5
Off Cycle
Follow these steps to review your data in the Off Cycle tab of the Compliance Summary:
1.
From the default Compliance Summary page, click the Off Cycle tab.
The Off Cycle page displays. Refer to Figure 94.
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Figure 94: Compliance Summary - Off Cycle
Note: Click the Export to Excel button to download all products under the Off Cycle
tab.
2.
Review your information for accuracy.
The Module organizes the full list by Drug Identifier and Manufacturer Name, and
includes Reporting Period, Wholesale Acquisition Cost, and Status fields.
3.5.6
Expired
Follow these steps to review your data in the Expired tab of the Compliance Summary:
1.
2.
From the default Compliance Summary page, click the Expired tab.
The Expired page displays. Refer to Figure 95.
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Figure 95: Compliance Summary - Expired
Note: Click the Export to Excel box if you need to download all products under the
Expired tab.
3.
Review your information for accuracy.
The Module organizes the full list by Drug Identifier and Manufacturer Name and
includes First Marketing Date and Expiration Date of Final Lot Sold fields.
3.6 Generate One-Time Password
Once you successfully enter product and financial data in the ASP Module, you can generate a
one-time password (OTP) for each manufacturer name. Note the following about OTPs:
•
•
•
•
•
OTPs protect sensitive information and product specific drug-data from tampering or
alterations by others outside of the Submitter or Certifier.
The OTP is a one-time authentication step to link a Submitter to a Certifier within the
system. This step does not need to take place during every submission. There can only
be one active Certifier per manufacturer. If the Certifier changes, the Submitter must
create and share a new OTP with the new Certifier.
The Submitter and Certifier cannot be the same person within your organization.
You can share the OTP with the Certifier. This passcode will remain the same for as long
as the Certifier is the same person in your organization who uses the ASP Module.
If the OTP expires, you can generate another OTP and provide it to the Certifier again.
Note: Refer to the Certifier User Guide for more information about the Certifier role.
Follow these steps to generate an OTP:
1.
From the Medicare Part B ASP Homepage, click the Generate One-Time Password
tab.
The Generate One-Time Password page opens. Refer to Figure 96.
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Figure 96: Generate One-Time Password
2.
Click the -Select- box under Manufacturer Name (required) to expand the list. Refer to
Figure 97.
Figure 97: Generate One-Time Password - Manufacturer Name
3.
Select the appropriate manufacturer name.
A new OTP displays. Refer to Figure 98.
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Figure 98: Generate One-Time Password - Password Created
4.
Click Copy OTP to copy your OTP.
Hover text indicates that you have successfully copied the new password. Refer to
Figure 99.
Figure 99: Generate One-Time Password - Password Copied
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5.
Copy the OTP and send it to your Certifier. You must recreate the OTP if the Certifier
cannot confirm the OTP on the Module, or if it expires.
Note: A message displays at the bottom of the window noting the expiration date for
your new password. The Certifier must log in to the ASP Module to use that OTP before
the noted expiration date.
Note: An OTP is only valid for seven days. After seven days, you must generate a new
OTP.
3.7 Assumptions
Drug manufacturers can submit comments regarding their certifications to CMS. Manufacturers
may submit these comments for either the current or prior reporting periods. Each quarter,
manufacturers will submit these comments for the current reporting period, or they may submit
assumptions for any previous quarters they are restating and resubmitting. Submitters can enter
assumptions, but certifiers must complete the assumptions form before certification.
3.7.1
Reasonable Assumptions
Follow these steps to submit certification assumptions to CMS:
1.
From the Medicare Part B Average Sales Price homepage, click the Assumptions
tab.
The Assumptions page opens, and defaults to the current quarter and year. Select the
appropriate reporting period before clicking the Reasonable Assumptions tab. Refer to
Figure 100.
Figure 100: Assumptions
Note: Click the Reporting Period (Required) tab in the top left to scroll through
previous quarters.
2.
Click the Reasonable Assumptions Form button.
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The Reasonable Assumption Form window displays. The Module automatically
defaults to the Reporting Period selected on the Assumptions default page with a
Manufacturer Name (required) drop-down menu and empty required response fields.
Refer to Figure 101.
Figure 101: Reasonable Assumptions Form
3.
4.
From the Manufacturer Name (required) drop-down menu, click the -Select- dropdown menu to expand the list and select the manufacturer name.
Click View All to view all the required response fields. Refer to Figure 102.
• Bona Fide Service Fees
• Bundled Sales
• Price Concessions and Discounts
• Reporting of Products with Zero, Negative, or False Positive ASPs
• Sales Excluded from Best Price
• Sales to U.S. Territories
• Time Value of Money
• Free Goods Not Contingent on a Purchase Requirement
• Value-Based Purchasing Agreements
• Sales to 340B Covered Entities
• Returned Goods
• Billing Corrections
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Figure 102: View All Required Response Fields
5.
Complete all the response fields. Enter NA if reasonable assumptions are not available
for a particular field.
Note: Each required field allows for 1,000 characters of text to provide a summary of the
assumption. If a response exceeds the character limit, please submit or upload the
additional verbiage on the Other Assumptions tab. Refer to Section 3.7.2 - Other
Assumptions for instructions.
6.
Click the Save Form button located at the bottom of the form. Refer to Figure 103.
Figure 103: Save Reasonable Assumptions Form
A message displays confirming you have successfully created your Reasonable
Assumptions. The Module lists saved forms under Added Forms. Refer to Figure 104.
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Figure 104: New Assumption Successfully Saved
7.
8.
To make any necessary revisions before submitting, click the Edit button.
If the submission does not require additional revisions, click the Submit button.
A message displays confirming you have successfully submitted your Reasonable
Assumptions. Refer to Figure 105.
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Figure 105: Reasonable Assumptions Successfully Submitted
3.7.2
Other Assumptions
This section provides instructions on how drug manufacturers can submit comments regarding
their certifications to CMS via Create Assumptions or Upload Assumptions.
3.7.2.1
Create Assumptions
Follow these steps to create an assumption:
1.
From the Medicare Part B Average Sales Price homepage, click the Assumptions
tab. The Module automatically defaults to the Reasonable Assumptions tab. Click the
Other Assumptions tab. Refer to Figure 106.
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Figure 106: Create Other Assumptions
Note: Click the Reporting Period tab in the top left to view previous quarters. Use the
drop-down menu to navigate to select the appropriate quarter.
2.
Click the Other Assumptions file button.
The Module automatically defaults to the Create Assumptions radio button with a
Manufacturer Name (required) drop-down menu and empty Short Description and
Text for Assumption file fields. Refer to Figure 106.
3.
4.
From the Manufacturer Name (required) drop-down menu, click the -Select- dropdown menu to expand the list and select the manufacturer name.
Complete the Short Description and Text for Assumption file fields.
Note: The Short Description field is optional and allows for 500 characters of text to
provide a summary of the complete assumption you are submitting to CMS. The Text
for Assumption file field is required and allows for 1,000 characters to provide as much
detail as possible related to the selected period’s financial submission.
5.
Click the Save Form button.
A message displays confirming you have successfully created your Assumption. Refer
to Figure 107.
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Figure 107: Other Assumptions Saved Successfully
3.7.2.2 Upload Assumption File
Follow these steps to upload an assumption file to the Module:
1.
Click the Other Assumptions file tab.
The Create Assumption or Upload Assumption File window displays. The Module
automatically defaults to the Create Assumption radio button.
2.
Click the Upload Assumption File radio button.
A Manufacturer Name (required) drop-down menu and empty File Description
(required) field display. Refer to Figure 108.
Figure 108: Upload Assumptions
3.
From the Manufacturer Name (required) drop-down menu, click the -Select- dropdown menu to expand the list and select the manufacturer name.
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4.
5.
In the File Description field, enter your assumption about a data submission. You have
500 characters of total text to comment about your submission in this section.
Click Select File to browse your desktop and upload your Assumption File to the
Module. You may also drag your Assumption File into the Select File box.
A message opens to confirm you have successfully uploaded your Assumption File.
Refer to Figure 109.
Figure 109: Upload Assumption File - Successfully Added
4.
Technical Support Contact Information
Contact the FFSDCS (ASP) Application Helpdesk for issues such as:
•
•
•
•
Account unlock
Password reset
Registration process questions
System availability escalations
Table 1 provides contact information for technical support.
Table 1: Technical Support Contacts
Email Address
[email protected]
Phone
Number
1-844-8760765
Hours
9:00 a.m. to 6:00 p.m. Eastern Standard Time (EST),
Monday through Friday
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Appendix A: Field Definitions
Table 2 provides an overview of field definitions for this document.
Table 2: Field Definitions
Column/Field Name
Manufacturer Name
Format
Alphanumeric
Allowed/Sample Values
Required/Optional
Maximum of 250
characters
Required
Notes
• When entering product data for the same
Manufacturer more than once, be sure the
spelling matches.
• Special characters (comma, dash, period)
allowed.
NDC1
5-digit
number
e.g., 12345
Required
• First segment of the National Drug Code (NDC)
that identifies the labeler. Products that do not
have an NDC should only use the Alternate ID
column.
• Not required if the product has an Alternate ID.
• Leading zero allowed.
NDC2
NDC3
Alternate ID
4-digit
number
e.g., 1234
2-digit
number
e.g., 12
alphanumeric
maximum of 23
characters
Required
• Not required if the product has an Alternate ID.
• The NDC2 is the sixth through the ninth digits
of the 11-digit NDC that identifies the product.
Required
• Not required if the product has an Alternate ID.
• The NDC3 is the last two digits of the 11-digit
NDC that identify the package size.
Required
• Not required if the product has an NDC. Must
match product ID exactly as listed publicly on
the manufacturer’s website.
• Special characters (colon, dash, period)
allowed.
Alternate ID Website
URL
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e.g.,
http://www.medicare.gov
NA
Must have http:// or https:// prefix.
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Column/Field Name
Format
Allowed/Sample Values
Required/Optional
Notes
Brand Name
Alphanumeric
Maximum of 250
characters
Optional
Enter strength and package size in their
respective fields unless it is a part of the
registered brand name.
Generic Name
Alphanumeric
Maximum of 250
characters
Required
Refer to valid values in Generic Name.
Volume Per Item
Numeric
NA
Required
For Alternate ID, report the volume amount in one
item. (For instance, enter 10 for 10 ml in one vial,
and enter 1 for powders, sheets, or patches.)
Unit for Volume per
Item
NA
NA
NA
See valid value in Unit of Volume per Item. For
example, for Alternate ID, select EACH for
powders, sheets, or patches.
Number of Items Per
NDC or Alternate ID
Numeric
Maximum of 9 digits and
2 decimal places
Required
• For NDCs: Indicates the number units within
the NDC package (for instance, enter 5 for 5
vials in a package).
• For Alternate IDs: Indicates the number of units
within the Alternate ID. (for instance, enter 5 for
5 grafts in a package).
Package Type
Alphanumeric
2 characters
Required
Enter SD, MD, or NA. (SD = Single dose, MD =
Multi dose, NA = Not Applicable)
Strength
Numeric
e.g., 300
Required
NA
Unit for Strength
NA
NA
NA
See valid values in Unit for Strength
FDA Application
Number/Registration
Number
Alphanumeric
Maximum of 6 characters
Required
• Enter FDA Application Number for NDCs and
Registration Number for Alternate IDs.
FDA Application
Supplement Number
Alphanumeric
• Enter Facility Registration Number for Human
Cells, Tissues, and Cellular and Tissue-Based
Products (HCT/Ps).
Maximum of 9 characters
Optional
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Column/Field Name
Format
Allowed/Sample Values
Required/Optional
Notes
Additional FDA
Application Number #1
Alphanumeric
Maximum of 6 characters
Optional
NA
Additional FDA
Application Supplement
Number #1
Alphanumeric
Maximum of 9 characters
Optional
NA
Additional FDA
Application Number #2
Alphanumeric
Maximum of 6 characters
Optional
NA
Additional FDA
Application Supplement
Number #2
Alphanumeric
Maximum of 9 characters
Optional
NA
FDA
Approval/Registration
Date
MM/DD/YYYY
e.g., 01/01/2023
Required
Must be prior to the current submission period
start date.
FDA Approval Type
NA
NA
Required
Refer to valid values in FDA Approval Type.
First Marketing Date
MM/DD/YYYY
e.g., 01/01/2023
Required
• Must be on or after the FDA Approval Date.
• Must be prior to the current submission period
start date. If the date is after the current
submission period start date, it must be
submitted as an off-cycle submission.
• NDC: For drugs marketed under an FDAapproved application (e.g., Abbreviated New
Drug Application (ANDA), Biologics License
Application (BLA), New Drug Application
(NDA)), the earliest date the drug was first
marketed under the application number by any
labeler. If a drug was purchased or otherwise
acquired from another labeler, the First
Marketing Date should be equal to the First
Marketing Date of the original product.
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Column/Field Name
Format
Allowed/Sample Values
Required/Optional
Notes
First Marketing Date
(continued)
MM/DD/YYYY
e.g., 01/01/2023
Required
• Alternate ID: For products marketed under an
FDA-approved application/registration (e.g.,
510(k), HCT/P, Premarket Approval (PMA)),
the earliest date the product was first marketed
under the application/registration number by
any labeler. If a product was purchased or
otherwise acquired from another labeler, the
date should be equal to the First Marketing
Date of the original product.
Date of First Sale for
this Product
MM/DD/YYYY
e.g., 01/01/2023
Required
• Must be after the First Marketing Date.
• Must be prior to the current submission
reporting period start date unless it is an offcycle submission.
• NDC: The date of first sale of individual NDCs.
• Alternate ID: The date of first sale of individual
Alternate IDs.
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Appendix B: Revision History
Table 3 provides a revision history for this document.
Table 3: Revision History
Version
Number
Date
Description of Change
1.0
03/15/2024
Index
Analytics/DCCA
Initial version of ASP Data Collection System
Submitter User Guide
2.0
07/11/2025
Index
Analytics/DCCA
• Updated based on updates to the ASP Data
Collection System.
Author/Editor
• Made various font, grammatical, punctuation,
shading, formatting, date, version, pagination,
glossary, and alignment corrections.
2.1
08/29/2025
Index
Analytics/DCCA
• Updated Section 3.7.
• Made various font, grammatical, punctuation,
shading, formatting, date, version, pagination,
glossary, and alignment corrections.
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Appendix C: Glossary
Table 4 provides a list of terms, acronyms, and definitions in this document.
Table 4: Glossary
Expanded Form
Acronym/Term
Definition
510(k)
NA
A 510(k) submission is the mechanism through which the
majority of medical devices obtain U.S. marketing clearance.
Such devices include catheters, contact lenses, and
absorbable sutures.
Abbreviated New
Drug Application
ANDA
An ANDA is an application for a U.S. generic drug approval for
an existing licensed medication or approved drug. Authorized
generics do not require ANDAs.
Average Sales
Price
ASP
ASP refers to the price at which an organization typically sells
a certain class of good or service. CMS uses manufacturerreported ASPs, based on manufacturers’ actual quarterly drug
sales, to calculate provider payment amounts for these drugs.
Federal law defines the price.
Biologics License
Application
BLA
A BLA is used to request permission to introduce or deliver a
biologic product into interstate commerce.
Center for
Medicare
Management
CMM
The CMM oversees the fee-for-service Medicare program.
Centers for
Medicare &
Medicaid Services
CMS
CMS is a federal agency within the U.S. Department of Health
and Human Services that administers the Medicare program
and works in partnership with state governments to administer
Medicaid, the State Children’s Health Insurance Program, and
health insurance portability standards.
Consolidated
Appropriations Act,
2021
CAA
The CAA establishes protections for consumers related to
surprise billing and transparency in health care. The No
Surprises Act (NSA) is part of the CAA.
Eastern Standard
Time
EST
EST is the standard time in the 5th time zone west of
Greenwich, reckoned at the 75th meridian. This time zone is
in the eastern part of the United States.
Fee-for-Service
Data Collection
System
FFSDCS
The FFSDCS is an instrument to collect cost, revenue,
utilization, and other information for FFS claims.
Human Cells,
Tissues, and
Cellular Products
HCT/P
HCT/Ps include human cells or tissue intended for
implantation, transplantation, infusion, or transfer into a
human recipient. The FDA Center for Biologics Evaluation and
Research (CBER) regulates HCT/Ps.
Interactive Voice
Response
IVR
IVR is a technology that allows a computer to detect voice and
DTMF keypad inputs.
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Expanded Form
Acronym/Term
Definition
Medicare
NA
Medicare is the federal system of health insurance for people
over 65 years of age and for certain younger people with
disabilities.
Medicare Part B
NA
Medicare Part B is the part of Medicare that covers doctor
services, outpatient hospital care, and other medical services
that Part A does not cover such as physical and occupational
therapy, X-rays, medical equipment, or limited ambulance
service.
New Drug
Application
NDA
An NDA is the vehicle through which drug sponsors formally
propose that the FDA approve a new pharmaceutical drug for
sale and marketing.
Okta
NA
Okta is an enterprise-grade, identity management service,
built for the cloud, but compatible with many on-premises
applications.
One-Time
Password
OTP
An OTP is a password that is valid for only one login session
or transaction.
Premarket
Approval
PMA
PMA is the FDA process of scientific and regulatory review to
evaluate the safety and effectiveness of Class III medical
devices. Such devices include implants, ventilators, and
pacemakers.
Short Message
Service
SMS
SMS is a text messaging service component of phone, web,
or mobile communication systems. It uses standardized
communication protocols to allow fixed-line or mobile phone
devices to exchange short text messages.
Social Security Act
SSA
The SSA is a law that provides income to retired workers aged
65 or older.
Uniform Resource
Locator
URL
The URL is a global address of documents and other
resources on the World Wide Web.
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Appendix D: Figures and Tables
List of Figures
Figure 1: Logging in Using MFA - ASP Module Login.................................................................. 2
Figure 2: Logging in Using MFA - Select MFA Device Type Drop-Down Menu ........................... 3
Figure 3: Logging in Using MFA - Multi-Factor Authentication - (IVR) Example ........................... 4
Figure 4: Logging in Using MFA - Multi-Factor Authentication - Verify MFA Code ....................... 5
Figure 5: Logging in Using MFA - My Portal Landing Page ......................................................... 5
Figure 6: Logging in Using MFA - My Portal Landing Page - FFSDCS Drop-down Menu ............ 6
Figure 7: Logging in Using MFA - ASP Data for Drugs and Biologics Under Medicare Part B ..... 6
Figure 8: Medicare Part B Average Sales Price Homepage ........................................................ 7
Figure 9: Manage NDC1/ALT ID Page - Assign NDC1 ................................................................ 8
Figure 10: Manage NDC1/ALT ID Page - Assign NDC1 Drop-down Menu .................................. 9
Figure 11: Manage NDC1/ALT ID Page - Enter NDC1 Manufacturer Name ................................ 9
Figure 12: Manage NDC1/ALT ID - NDC1 Assigned Successfully............................................. 10
Figure 13: Manage NDC1/ALT ID Page - Assign ALT ID .......................................................... 11
Figure 14: Manage NDC1/ALT ID Page - Assign ALT ID Drop-down Menu .............................. 11
Figure 15: Manage NDC1/ALT ID Page - Enter ALT ID Manufacturer Name ............................ 12
Figure 16: Manage NDC1/ALT ID - ALT ID Assigned Successfully ........................................... 12
Figure 17: Request New NDC1/ALT ID/Manufacturer/Generic Name Page .............................. 13
Figure 18: Request New NDC1/ALT ID/Manufacturer/Generic Name Page - Add New NDC1 .. 13
Figure 19: Request New NDC1 - Field Filled ............................................................................. 14
Figure 20: Request New NDC1 - NDC1 Successfully Added .................................................... 14
Figure 21: Request New NDC1/ALT ID/Manufacturer/Generic Name Page - Add New ALT ID . 15
Figure 22: Request New Alternate ID - ALT ID Field Filled ........................................................ 16
Figure 23: Request New Alternate ID - ALT ID Successfully Added .......................................... 16
Figure 24: Request New Manufacturer Name ........................................................................... 17
Figure 25: Request New Generic Name .................................................................................... 17
Figure 26: Request New Manufacturer Name - Field Populated ................................................ 18
Figure 27: Request New Generic Name - Field Populated ........................................................ 18
Figure 28: Request New Manufacturer Name - Successfully Added ......................................... 19
Figure 29: Request New Generic Name - Successfully Added .................................................. 19
Figure 30: Product Data - Main Drop-down Menu ..................................................................... 20
Figure 31: Add/Update Product Data ........................................................................................ 20
Figure 32: Add/Update Product Data Fields Populated ............................................................. 23
Figure 33: Add/Update Product Data Successfully Added ......................................................... 24
Figure 34: Add Product Data by Alternate ID ............................................................................ 25
Figure 35: Add Product Data by Alternate ID - Fields Populated ............................................... 25
Figure 36: Add Product Data by Alternate ID - Additional Fields ............................................... 27
Figure 37: Product Data by Alternate ID Added Successfully .................................................... 28
Figure 38: Update Product Data - Drug Identifier & Manufacturer Name ................................... 28
Figure 39: Update Product Data by NDC .................................................................................. 29
Figure 40: Update Product Data by NDC - Data Updated Successfully ..................................... 30
Figure 41: Update Product Data by Alternate ID ....................................................................... 30
Figure 42: Update Product Data by Alternate ID - Drug Identifier Drop-down Menu .................. 31
Figure 43: Update Product Data by Alternate ID - Updated Successfully .................................. 32
Figure 44: Upload Product Data - New or Corrected ................................................................. 33
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Figure 45: Upload Product Data - Uploading Files from Desktop .............................................. 33
Figure 46: Upload Product Data - New File Successfully Uploaded .......................................... 34
Figure 47: Upload Product Data - Uploaded Files ..................................................................... 34
Figure 48: Upload Product Data - Full Report of Transmitted Drugs via File Upload ................. 35
Figure 49: Upload Product Data - Reported Rejection Details ................................................... 36
Figure 50: Product Data - View Active Drugs ............................................................................ 37
Figure 51: Product Data - View Expired Drugs .......................................................................... 38
Figure 52: Financial Data - Main Drop-down ............................................................................. 38
Figure 53: Add/Update Financial Data ...................................................................................... 39
Figure 54: Add/Update Financial Data 505(b)(2) ....................................................................... 40
Figure 55: Add/Update Financial Data 505(b)(2) Products List.................................................. 40
Figure 56: Add/Update Financial Data 505(b)(2) Products List.................................................. 41
Figure 57: 505(b)(2) Confirmation ............................................................................................. 41
Figure 58: Add/Update Financial Data 505(b)(2) Successfully Updated .................................... 42
Figure 59: Add/Update Financial Data - Drug Identifiers With Missing or Incorrect Data ........... 43
Figure 60: Add/Update Financial Data Successfully Added ....................................................... 44
Figure 61: Add/Update Financial Data - Error Menu .................................................................. 44
Figure 62: Add/Update Financial Data - View Errors/Warnings Page ........................................ 45
Figure 63: Add/Update Financial Data - Successfully Updated ................................................. 45
Figure 64: Add/Update Financial Data - Certified Drugs ............................................................ 46
Figure 65: Add/Update Financial Data - Certified Drugs More Information ................................ 47
Figure 66: Upload Product Data - New or Corrected ................................................................. 47
Figure 67: Upload Financial Data - Uploading Files From Desktop ........................................... 48
Figure 68: Upload Financial Data Page - New File Successfully Uploaded ............................... 49
Figure 69: Upload Financial Data - Uploaded Files ................................................................... 49
Figure 70: Upload Financial Data - Report of Transmitted Drugs via File Upload ...................... 50
Figure 71: Upload Financial Data - Reported Rejection Details ................................................. 51
Figure 72: Financial Data - Main Dropdown .............................................................................. 52
Figure 73: Financial Data - Add/Update Restate Financial Data ................................................ 52
Figure 74: Add/Update Restate Financial Data - Drug Identifier Drop-down .............................. 53
Figure 75: Add/Update Restate Page - Review Restatement List ............................................. 53
Figure 76: Add/Update Restate Page - Restate Data Successfully Saved ................................ 54
Figure 77: Financial Data - Main Drop-down ............................................................................. 55
Figure 78: Upload Financial Data for Prior Quarters Restate Financial Data ............................. 55
Figure 79: Upload Financial Data for Prior Quarters - Uploading Files From Desktop ............... 56
Figure 80: Upload Financial Data for Prior Quarters - New File Successfully Uploaded ............ 56
Figure 81: Upload Financial Data for Prior Quarters - Uploaded Files ....................................... 57
Figure 82: Upload Financial Data for Prior Quarters - Report of Transmitted Drugs .................. 58
Figure 83: Upload Financial Data for Prior Quarters - Reported Rejection Details..................... 59
Figure 84: Compliance Summary .............................................................................................. 60
Figure 85: Compliance Summary - Add Data Screen ................................................................ 61
Figure 86: Compliance Summary - Successfully Saved ............................................................ 62
Figure 87: Compliance Summary - All Pending Certification ..................................................... 62
Figure 88: Compliance Summary - Pending Certification .......................................................... 63
Figure 89: Compliance Summary - Pending Restatement Certification ..................................... 64
Figure 90: Compliance Summary - All Certified ......................................................................... 65
Figure 91: Compliance Summary - Certified.............................................................................. 66
Figure 92: Compliance Summary - Restated and Certified ........................................................ 67
Figure 93: Compliance Summary - New .................................................................................... 68
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Figure 94: Compliance Summary - Off Cycle ............................................................................ 69
Figure 95: Compliance Summary - Expired ............................................................................... 70
Figure 96: Generate One-Time Password ................................................................................. 71
Figure 97: Generate One-Time Password - Manufacturer Name............................................... 71
Figure 98: Generate One-Time Password - Password Created................................................. 72
Figure 99: Generate One-Time Password - Password Copied .................................................. 72
Figure 100: Assumptions .......................................................................................................... 73
Figure 101: Reasonable Assumptions Form ............................................................................. 74
Figure 102: View All Required Response Fields........................................................................ 75
Figure 103: Save Reasonable Assumptions Form .................................................................... 75
Figure 104: New Assumption Successfully Saved..................................................................... 76
Figure 105: Reasonable Assumptions Successfully Submitted ................................................. 77
Figure 106: Create Other Assumptions ..................................................................................... 78
Figure 107: Other Assumptions Saved Successfully ................................................................. 79
Figure 108: Upload Assumptions .............................................................................................. 79
Figure 109: Upload Assumption File - Successfully Added........................................................ 80
List of Tables
Table 1: Technical Support Contacts ........................................................................................ 80
Table 2: Field Definitions........................................................................................................... 81
Table 3: Revision History .......................................................................................................... 85
Table 4: Glossary ...................................................................................................................... 86
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| File Type | application/pdf |
| File Title | Average Sales Price (ASP) Submitter User Guide |
| Subject | Submitter User Guide for the ASP Module |
| Author | CMS |
| File Modified | 2025-08-28 |
| File Created | 2025-08-28 |